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510(k) K923218

NITANIUM PALATAL EXPANDER by Ortho Organizers, Inc. — Product Code EJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1993
Date Received
July 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

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